Coherus Oncology, Inc. reports commercial-stage oncology developments centered on LOQTORZI® (toripalimab-tpzi), an approved next-generation PD-1 inhibitor for recurrent or metastatic nasopharyngeal carcinoma. Company updates also cover its antibody immunotherapy pipeline, including tagmokitug, an anti-CCR8 cytolytic antibody, and casdozokitug, an IL-27 antagonistic antibody, across solid-tumor programs such as liver, prostate, head and neck, colorectal, gastric and esophageal cancers.
Recurring news includes financial results, LOQTORZI revenue commentary, clinical-development updates, strategic partnerships, investor-conference presentations, public common-stock offerings, debt reduction and other capital-structure actions tied to the company's transition from biosimilars to innovative oncology.
Coherus Biosciences has appointed Dr. Jill O’Donnell-Tormey, a leader in cancer immunotherapy, to its Board of Directors. With over 30 years at the Cancer Research Institute, she will also serve on the Nominating and Corporate Governance Committee. CEO Denny Lanfear emphasized her experience in advancing immunotherapies. Dr. O’Donnell-Tormey expressed enthusiasm for helping Coherus deliver new cancer treatments. Coherus is focused on building a robust immuno-oncology franchise, with upcoming product launches including YUSIMRY™, aiming to enhance patient outcomes.
Coherus BioSciences (Nasdaq: CHRS) announced its participation in three investor conferences in May 2022. The BofA Securities 2022 Healthcare Conference will occur on May 12 at 3:00 p.m. ET, followed by the UBS Global Healthcare Conference on May 24 at 2:00 p.m. ET, and the H.C. Wainwright Global Investment Conference on May 25 at 9:00 a.m. ET. Audio webcasts of each presentation will be available on the Coherus investors’ page, with archived access for 30 days.
Coherus BioSciences (CHRS) reported Q1 2022 net sales of UDENYCA® at $60.1 million, down from $83 million in Q1 2021, attributed to increased competition. The company plans to resubmit the toripalimab BLA by mid-summer after addressing a complete response letter from the FDA. CIMERLI™ is advancing, with an action date set for August 2, 2022. R&D and SG&A expense guidance has been reduced by $20 million to $395-$430 million for the year. Coherus reported a net loss of $96.1 million in Q1 2022, improving from a $172.9 million loss in Q1 2021.
Coherus BioSciences, Inc. (NASDAQ: CHRS) has appointed Charlie Newton, a notable biotech strategist and CFO, to its Board of Directors. With nearly three decades of experience in healthcare investment banking, Newton is expected to enhance Coherus' immuno-oncology strategy. CEO Denny Lanfear recognizes his expertise in building shareholder value. Coherus is focusing on capitalizing on its commercial portfolio and advancing its pipeline, including a resubmission of a BLA for toripalimab to treat advanced nasopharyngeal carcinoma by mid-summer 2022.
Coherus BioSciences (CHRS) announced on April 27, 2022, the granting of stock options to 13 new employees totaling 240,000 shares. The options have an exercise price of $9.28, matching the closing trading price on that date. Among the granted options, two Vice Presidents received 45,000 shares each, while another received 50,000 shares. The remaining 100,000 shares were allocated to ten non-officer employees. This initiative is part of the 2016 Employment Commencement Incentive Plan to attract new talents to the company.
Coherus BioSciences (Nasdaq: CHRS) and Junshi Biosciences announce the FDA's complete response letter (CRL) regarding their Biologics License Application (BLA) for toripalimab, aimed at treating advanced nasopharyngeal carcinoma (NPC). The CRL requests a quality process change, which both companies believe is manageable. They plan to resubmit the BLA by mid-summer 2022, followed by a six-month FDA review timeline. Inspections in China for FDA approval are delayed due to COVID-19 restrictions. If approved, toripalimab will be the first immuno-oncology agent for NPC in the U.S.
Coherus BioSciences (Nasdaq: CHRS) has announced that its first quarter 2022 financial results will be released after market close on May 5, 2022. A conference call will follow at 4:30 p.m. ET, where management will discuss the results and provide a business update. The corrected press release highlighted the new start time for the call, which was previously misstated. Interested parties can access the webcast and financial results on the company’s investor relations website.
Coherus BioSciences (CHRS) will release its first quarter 2022 financial results on May 5, 2022, after market close. Following the announcement, management will host a conference call at 5 p.m. ET to discuss the results and provide a business update. Interested parties can access the call by dialing (844) 452-6826 for U.S. and Canadian callers or (765) 507-2587 internationally. A replay will be available on the company's website for 30 days following the event.
Coherus BioSciences (Nasdaq: CHRS) and Shanghai Junshi Biosciences announced that the FDA has granted Orphan Drug Designation for toripalimab, a PD-1 inhibitor, for small cell lung cancer (SCLC). This designation, meant for rare diseases, aims to boost the drug's development and commercialization. SCLC has a poor prognosis, with a five-year survival rate of around 20%. The ongoing JUPITER-08 Phase 3 trial is assessing toripalimab combined with chemotherapy as a first-line treatment for extensive stage SCLC. Topline data is expected later this year.
Coherus (CHRS) and Junshi Biosciences announced significant results from the JUPITER-02 study, a Phase 3 trial assessing toripalimab with chemotherapy for advanced nasopharyngeal carcinoma (NPC).
The trial revealed a median progression-free survival (PFS) of 21.4 months for the toripalimab group versus 8.2 months for placebo, showing a strong statistical significance. Interim overall survival (OS) data indicates a 41% reduced risk of death.
The FDA has granted breakthrough therapy designation for toripalimab, with a biologics license application currently under priority review.